Olmesartan: uses, appearance and warnings

Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents. Olmesartan medoxomil tablets are an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adult and pediatric patients six years of age and older, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1 ).

• 5 mg yellow, round, biconvex, film-coated tablets debossed with "C51" on one side and plain on other side. • 20 mg white, round, biconvex, film-coated tablets debossed with "C53" on one side and plain on other side. • 40 mg white, oval, biconvex, film-coated tablets debossed with "C54" on one side and plain on other side. Tablets: 5 mg, 20 mg, and 40 mg (3).

Olmesartan medoxomil tablets, USP are supplied as yellow, round, biconvex, film-coated, non-scored tablets debossed with "C51" on one side and plain on other side containing 5 mg of olmesartan medoxomil, as white, round, biconvex, film-coated, non-scored tablets debossed with "C53" on one side and plain on other side containing 20 mg of olmesartan medoxomil and as white, oval, biconvex, film-coated, non-scored tablets debossed with "C54" on one side and plain on other side containing 40 mg of olmesartan medoxomil. Tablets are supplied as follows: 5 mg 20 mg 40 mg Bottle of 30 NDC 72603-950-01 NDC 72603-951-01 NDC 72603-952-01 Bottle of 90 NDC 72603-950-02 NDC 72603-951-02 NDC 72603-952-02 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see Drug Interactions ( 7.3 )]. Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes (4).

• Avoid fetal ( in utero ) exposure ( 5.1 ). • Use of olmesartan medoxomil tablets in children <1 year of age is not recommended ( 5.2 ). • Observe for signs and symptoms of hypotension in volume- or salt-depleted patients with treatment initiation ( 5.3 ). • Monitor for worsening renal function in patients with renal impairment ( 5.4 ). • Sprue-like enteropathy has been reported. Consider alternative antihypertensive therapy in cases where no other etiology is found ( 5.5 ). 5.1 Fetal Toxicity Olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system (RAS) during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible [see Use in Specific Populations ( 8.1 )]. 5.2 Morbidity in Infants Use of olmesartan medoxomil tablets in children <1 year of age is not recommended. Drugs that act directly on the renin-angiotensin-aldosterone system (RAAS) can have effects on the development of immature kidneys [see Use in Specific Populations ( 8.4 )]. 5.3 Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin-aldosterone system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may be anticipated after initiation of treatment with olmesartan medoxomil tablets. Initiate treatment under close medical supervision and consider starting at a lower dose. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline [see Dosage and Administration ( 2.1 )]. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. 5.4 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil tablets In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death. Similar results may be anticipated in patients treated with olmesartan medoxomil tablets [see Dosage and Administration ( 2.1 ), Drug Interactions ( 7.3 ), Use in Specific Populations ( 8.7 ), and Clinical Pharmacology ( 12.3 )]. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil tablets in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected. 5.5 Sprue-like Enteropathy Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider alternative antihypertensive therapy in cases where no other etiology is identified. 5.6 Hyperkalemia Serum potassium should be monitored in patients receiving olmesatan medoxomil tablets. Drugs that inhibit the renin angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium containing salt substitutes [ see Drug Interactions ( 7.3 ) ].

The most common adverse reaction in adults was dizziness (3%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact North Star Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Olmesartan medoxomil tablets has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 for at least 1 year. …

• Agents increasing potassium levels may lead to increase in serum potassium ( 7.1 ). • NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.2 ). • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.3 ). • Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.4 ). • Lithium: Increases in serum lithium concentrations and lithium toxicity ( 7.5 ). 7.1 Agents Increasing Serum Potassium Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium. …